Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Ameriwater · Predicate Candidate Screening

11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

141 daysmedian FDA review time

350 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K141213	AMERIWATER OZONE DISINFECTION SYSTEM	Ameriwater	2014-12-10	212	0
K142285	AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan,	Ameriwater	2014-12-01	105	0
K133783	AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT	Ameriwater	2014-04-16	125	0
K131904	MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZA	Ameriwater	2013-11-13	141	0
K131622	MROZ REVERSE OSMOSIS SYSTEM	Ameriwater	2013-09-20	109	0
K121022	AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL &	Ameriwater	2012-09-17	166	0
K111740	AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATI	Ameriwater	2011-10-05	106	1
K051031	AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIAL	Ameriwater	2006-01-06	259	0
K021560	MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALY	Ameriwater	2003-08-14	458	0
K030059	PORTABLE RO+ MODEL MROS09	Ameriwater	2003-04-07	90	0
K991519	AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS	Ameriwater	2000-04-14	350	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda